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  • Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

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Surgery
Protocol
Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial
  1. Mohit Bhandari1,
  2. P J Devereaux2,
  3. Thomas A Einhorn3,
  4. Lehana Thabane4,
  5. Emil H Schemitsch5,
  6. Kenneth J Koval6,
  7. Frede Frihagen7,
  8. Rudolf W Poolman8,
  9. Kevin Tetsworth9,
  10. Ernesto Guerra-Farfán10,
  11. Kim Madden11,
  12. Sheila Sprague12,
  13. Gordon Guyatt4,
  14. HEALTH Investigators
    1. 1Department of Surgery, McMaster University, Hamilton, Ontario, Canada
    2. 2Department of Medicine, McMaster University, Hamilton, Ontario, Canada
    3. 3Boston University Medical Center, Boston, Massachusetts, USA
    4. 4Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada
    5. 5St Michael's Hospital, Toronto, Ontario, Canada
    6. 6Department of Orthopaedic Surgery, Orlando Regional Medical Centre, Orlando, Florida, USA
    7. 7Orthopaedic Centre, Ulleval University Hospital, Oslo, Norway
    8. 8Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis/University of Amsterdam, Amsterdam, the Netherlands
    9. 9University of Queensland, Queensland, Australia
    10. 10Department of Traumatology Orthopaedic Surgery and Emergency, University Hospital Vall d'Hebron, Barcelona, Spain
    11. 11Hamilton, Ontario, Canada
    12. 12McMaster University, Hamilton, Ontario, Canada
    1. Correspondence to Dr Mohit Bhandari; bhandam{at}mcmaster.ca

    Abstract

    Introduction Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.

    Methods and analysis HEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications—both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a χ2 test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs.

    Ethics and dissemination The HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151).

    Results Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.

    Trial registration number The HEALTH trial is registered with clinicaltrials.gov (NCT00556842).

    • SURGERY
    • ORTHOPAEDIC & TRAUMA SURGERY

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2014-006263

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